Home NDC 79753-045 COOLA CLASSIC SUNSCREEN FRAGRANCE FREE
Product NDC 79753-045
11-digit product format 797530045
Labeler code 79753
Product ID 79753-045_45ede361-ecc1-0474-e063-6294a90a9c2d
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler COOLA, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-01-01
Substance HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE
Active strength 100; 30; 80; 45 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base COOLA CLASSIC SUNSCREEN FRAGRANCE FREE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 100 mg/mL AVOBENZONE 30 mg/mL OCTOCRYLENE 80 mg/mL OCTISALATE 45 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79753-045-72 COOLA CLASSIC SUNSCREEN FRAGRANCE FREE 946 mL in 1 BOTTLE LOTION 946 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79753-045 COOLA CLASSIC SUNSCREEN FRAGRANCE FREE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [COOLA, LLC] 3 Current NDC, Legacy NDC, 1 package rows 20241025_cfc21b1a-4a26-1573-e053-2995a90a2d50.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 261 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Lip Cream SPF 15 ZINC OXIDE COSMAX USA, CORPORATION 29227121-e579-8eea-e063-6394a90a302f 2024-12-13 Warnings Exact identifier application number: M020 BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,AND OXYBENZONE Bobbi Brown Professional Cosmetics Inc. 03372376-ef03-943d-e063-6394a90a52ee 2024-12-13 Warnings Exact identifier application number: M020 WEIGHTLESS SKIN FOUNDATION BROAD SPECTRUM SPF 15 OCTINOXATE, TITANIUM DIOXIDE Bobbi Brown Professional Cosmetics Inc. fbd04b66-738b-2762-e053-6394a90a8b72 2024-12-13 Warnings Exact identifier application number: M020 Mentholatum Natural Ice Cherry DIMETHICONE, OCTINOXATE, OCTISALATE The Mentholatum Company 33f43f14-8e0b-41b1-8ad0-5723d2a7bf19 2024-12-13 Warnings Exact identifier application number: M020 Absolutely Natural Broad Spectrum SPF 8 Sunscreen ZINC OXIDE Absolutely Natural a26217cf-22ab-4c39-980a-b73467e16b91 2024-12-13 Warnings Exact identifier application number: M020 Calming Primer SPF 20 TITANIUM DIOXIDE AND ZINC OXIDE Colorescience d681cdb5-307e-4a2a-8e1d-2b29131d48d0 2024-12-13 Warnings Exact identifier application number: M020 Absolutely Natural Broad Spectrum SPF 15 Sunscreen ZINC OXIDE Absolutely Natural 8084a3ee-fe31-4cb4-8d3c-e4035d29e561 2024-12-13 Warnings Exact identifier application number: M020 Mineral Corrector Palette SPF 20 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Colorescience ab70122f-bd68-4781-841f-dc83284e1403 2024-12-13 Warnings Exact identifier application number: M020 Neutrogena Healthy Skin Radiant Tinted Moisturizer Sunscreen Broad Spectrum SPF 25, Sheer Ivory 10 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC 0a0654cc-ad47-2167-e063-6294a90a52f4 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals Daily Sheer Mineral Sunscreen SPF 40 ZINC OXIDE, TITANIUM DIOXIDE Babo Botanicals, Inc. f8adda52-e909-1905-e053-6294a90a3c78 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals Swim and Sport Mineral Sunscreen SPF 30 ZINC OXIDE Babo Botanicals, Inc. f8b1ea3a-d62e-e00d-e053-6394a90a5689 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals Swim and Sport Mineral Sunscreen Balm SPF 50 ZINC OXIDE Babo Botanicals, Inc. f8b272f6-8726-de1d-e053-6294a90a7b1e 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals Super Shield Sport Sunscreen SPF 50 ZINC OXIDE Babo Botanicals, Inc. e3ca7840-4882-d605-e053-2a95a90af6ab 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals SPF 30 Daily Sheer Tinted Sunscreen - Natural Glow MINERAL SUNSCREEN Babo Botanicals, Inc. ab39d9f0-d869-6f33-e053-2995a90a08d4 2024-12-12 Warnings Exact identifier application number: M020 Alumier MD Sheer Hydration TITANIUM DIOXIDE, ZINC OXIDE Alumier Labs 88dedeb8-963f-5849-e053-2995a90aab72 2024-12-12 Warnings Exact identifier application number: M020 Everyday Coverage Tinted Sunscreen - Extra Light Tint ZINC OXIDE MV Advanced 7834c649-5f6d-b005-e053-2a91aa0a1084 2024-12-12 Warnings Exact identifier application number: M020 Everyday Coverage Tinted Sunscreen - Light Tint ZINC OXIDE MV Advanced 783649af-d746-84a3-e053-2991aa0a9e3d 2024-12-12 Warnings Exact identifier application number: M020 Everyday Coverage Tinted Sunscreen - Medium Tint ZINC OXIDE MV Advanced 783649af-d768-84a3-e053-2991aa0a9e3d 2024-12-12 Warnings Exact identifier application number: M020 Babo SPF 30 Clear Zinc Fragrance Free Sport MINERAL SUNSCREEN Babo Botanicals, Inc. b1a9f76d-0cef-29da-e053-2995a90af34c 2024-12-12 Warnings Exact identifier application number: M020 Babo Baby Face Mineral Sunscreen MINERAL SUNSCREEN Babo Botanicals, Inc. b131664d-1ad2-0a2f-e053-2995a90acbda 2024-12-12 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 79753-045-72 79753004572 946 mL in 1 BOTTLE (79753-045-72) 946 ml 2018-01-01 0000-00-00 No No Current